{"schema_version":"secwatch.filing_event.v1","accession":"0001477932-24-006902","form_type":"8-K","ticker":"UEEC","cik":"0001096938","company_name":"United Health Products, Inc.","filed_at":"2024-11-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:07.657993+00:00","generated_at":"2026-05-30T04:18:40.213034+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"UHP FDA PMA update: supplemental study needed for organ space, 6-7 month delay","bullets":["FDA requires additional clinical data for CelluSTAT (HemoStyp) use in intestinal/thoracic procedures.","Pivotal study (232 patients, 118 treated) showed non-inferiority and superiority for time to hemostasis.","Company will enroll limited number of human subjects in multi-site supplemental study, taking ~6-7 months.","FDA review period remains paused until all deficiencies addressed; ~90 of 180 days elapsed.","Additional biocompatibility and sterility testing agreed with FDA; BIMO site inspections completed."],"urls":{"canonical":"https://secwatch.observer/filing/0001477932-24-006902","json":"https://secwatch.observer/filing/0001477932-24-006902.json","markdown":"https://secwatch.observer/filing/0001477932-24-006902.md","text":"https://secwatch.observer/filing/0001477932-24-006902.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1096938/000147793224006902/0001477932-24-006902-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1096938/000147793224006902/ueec_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T04:18:40.213034+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}